NeuroRPM
New Touch Digital Inc.NeuroRPM is a software application for the Apple Watch that uses machine learning to analyze motion sensor data to quantify motor symptoms like tremor, bradykinesia, and dyskinesia in adult Parkinson's disease patients. It helps clinicians remotely monitor symptom presence every 15 minutes, supporting both clinic and home use for improved patient management.
Intended Use
NeuroRPM is intended to quantify movement disorder symptoms during wake periods in adult patients 46 to 85 years of age with Parkinson's disease. These symptoms include tremor, bradykinesia, and dyskinesia. Intended for clinic and home environments.
Technology
NeuroRPM uses accelerometer and gyroscope sensors from the Apple Watch to collect motion data. These data are transmitted to cloud servers where machine learning models analyze them to generate binary classifications of tremor, bradykinesia, and dyskinesia every 15 minutes. Algorithm outputs are directly validated against clinical scales and symptom presence.
Performance
Bench testing confirmed the motion data recognition consistent and reliable without outliers. A clinical study with 36 Parkinson’s disease subjects compared symptom presence to clinical expert ratings and validated sensitivity and specificity for classification of tremor, bradykinesia, and dyskinesia. The device showed substantial equivalence to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/21/2022
8 months - 2
FDA Approval
3/17/2023
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